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Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial

RecruitingNAAges 16 Years - anyAllImperial College London
NCT02704520 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, TRIGGER is the only phase III clinical trial in the UK offering watch and wait. All patients will have post treatment MRI scans routinely performed, no change from the MERCURY trials high resolution MRI protocol is required. Patients will be randomised to either the control arm for management according to national guidelines - conventional MDT, clinical assessment post-treatment planning using the baseline MRI. Patients in the interventional arm will have their post treatment MRI scans read by a radiologist trained and supported to reliably report the mrTRG grade and have their management directed accordingly - 'Good response' (mrTRG 1\&2) - watch and wait (avoidance of surgery) offered. 'Poor response' (mrTRG 3-5) - local colorectal MDT is informed and uses information to discuss and agree next s

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive 2. Biopsy confirmed adenocarcinoma of radiologically defined rectum 3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT) Exclusion Criteria: 1. Metastatic disease 2. MRI, radiotherapy and/or chemotherapy contraindications 3. A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given 4. Previous malignancy within preceding 5 years if risk of recurrence \>5%
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What it tests

  • High resolution MRI scan
  • mrTRG assessment
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Where

10 sites
Aberdeen Royal Infirmary - NHS Grampion
Aberdeen, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
University Hospital of North Midlands NHS Trust - Royal Stoke
Stoke-on-Trent, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Colchester General Hospital
Colchester, United Kingdom
NHS Lanarkshire - Hairmyres Hospital
East Kilbride, United Kingdom
Diana Princess of Wales Hospital
Grimsby, United Kingdom

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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